Cleared Traditional

LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing

K172554 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery
May 2018
Decision
250d
Days
—
Risk

About This 510(k) Submission

K172554 is an FDA 510(k) clearance for the LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing, a Dressing, Wound, Drug, submitted by Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on May 1, 2018, 250 days after receiving the submission on August 24, 2017. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K172554 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2017
Decision Date May 01, 2018
Days to Decision 250 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class —

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